中华精神科杂志
中華精神科雜誌
중화정신과잡지
CHINESE JOURNA OF PSYCHIATRY
2008年
2期
85-88
,共4页
李华芳%马崔%王刚%谢世平%王晓萍%许秀峰%于欣%顾牛范
李華芳%馬崔%王剛%謝世平%王曉萍%許秀峰%于訢%顧牛範
리화방%마최%왕강%사세평%왕효평%허수봉%우흔%고우범
双相情感障碍%碳酸锂%随机对照试验%奎硫平
雙相情感障礙%碳痠鋰%隨機對照試驗%奎硫平
쌍상정감장애%탄산리%수궤대조시험%규류평
Bipolar disorder%Lithium carbonate%Randomized controlled trials%Quetiapine
目的 评价奎硫平单药治疗双相障碍急性躁狂患者的疗效及安全性.方法 采用随机、双盲双模拟、阳性药物平行对照、多中心研究.根据中国精神障碍分类与诊断标准第3版诊断为双相障碍躁狂发作,并且根据Young躁狂评定量表(YMRS)总分≥20分的住院患者被随机分配接受奎硫平(每日2次口服,最大剂量达800 mg/d)或碳酸锂(每日2次口服,最大剂量达2000 mg/d)治疗,共观察4周.主要疗效指标为从基线至治疗第28天YMRS总分的改变(末次观察值结转).安全性指标包括不良事件、实验室和心电图检查等.结果 共随机分配155例患者(奎硫平组为78例,碳酸锂组为77例).意向性治疗人群共154例(两组各77例).奎硫平和碳酸锂的平均剂量分别为642.9 mg/d和1377.7 mg/d.从基线至治疗第28天奎硫平组和碳酸锂组YMRS减分值分别为-18.2分和-15.9分.治疗第28天,奎硫平组的有效率(78%)明显高于碳酸锂组(60%),差异有统计学意义(P=0.013).奎硫平组和碳酸锂组的不良事件发生率分别为78%和69%.奎硫平在最大剂量达800 mg/d的情况下耐受性较好,其最常见的不良事件为便秘(35%)、头晕(15%)和腹泻(10%);碳酸锂组最常见的不良事件为恶心(17%)、便秘(13%)和呕吐(13%).碳酸锂组中有3例患者因不良事件而中止研究,其中有1例为严重不良事件;奎硫平组无因不良事件而中止的研究者.结论 奎硫平单药治疗双相障碍急性躁狂有效,且耐受性较好.
目的 評價奎硫平單藥治療雙相障礙急性躁狂患者的療效及安全性.方法 採用隨機、雙盲雙模擬、暘性藥物平行對照、多中心研究.根據中國精神障礙分類與診斷標準第3版診斷為雙相障礙躁狂髮作,併且根據Young躁狂評定量錶(YMRS)總分≥20分的住院患者被隨機分配接受奎硫平(每日2次口服,最大劑量達800 mg/d)或碳痠鋰(每日2次口服,最大劑量達2000 mg/d)治療,共觀察4週.主要療效指標為從基線至治療第28天YMRS總分的改變(末次觀察值結轉).安全性指標包括不良事件、實驗室和心電圖檢查等.結果 共隨機分配155例患者(奎硫平組為78例,碳痠鋰組為77例).意嚮性治療人群共154例(兩組各77例).奎硫平和碳痠鋰的平均劑量分彆為642.9 mg/d和1377.7 mg/d.從基線至治療第28天奎硫平組和碳痠鋰組YMRS減分值分彆為-18.2分和-15.9分.治療第28天,奎硫平組的有效率(78%)明顯高于碳痠鋰組(60%),差異有統計學意義(P=0.013).奎硫平組和碳痠鋰組的不良事件髮生率分彆為78%和69%.奎硫平在最大劑量達800 mg/d的情況下耐受性較好,其最常見的不良事件為便祕(35%)、頭暈(15%)和腹瀉(10%);碳痠鋰組最常見的不良事件為噁心(17%)、便祕(13%)和嘔吐(13%).碳痠鋰組中有3例患者因不良事件而中止研究,其中有1例為嚴重不良事件;奎硫平組無因不良事件而中止的研究者.結論 奎硫平單藥治療雙相障礙急性躁狂有效,且耐受性較好.
목적 평개규류평단약치료쌍상장애급성조광환자적료효급안전성.방법 채용수궤、쌍맹쌍모의、양성약물평행대조、다중심연구.근거중국정신장애분류여진단표준제3판진단위쌍상장애조광발작,병차근거Young조광평정량표(YMRS)총분≥20분적주원환자피수궤분배접수규류평(매일2차구복,최대제량체800 mg/d)혹탄산리(매일2차구복,최대제량체2000 mg/d)치료,공관찰4주.주요료효지표위종기선지치료제28천YMRS총분적개변(말차관찰치결전).안전성지표포괄불량사건、실험실화심전도검사등.결과 공수궤분배155례환자(규류평조위78례,탄산리조위77례).의향성치료인군공154례(량조각77례).규류평화탄산리적평균제량분별위642.9 mg/d화1377.7 mg/d.종기선지치료제28천규류평조화탄산리조YMRS감분치분별위-18.2분화-15.9분.치료제28천,규류평조적유효솔(78%)명현고우탄산리조(60%),차이유통계학의의(P=0.013).규류평조화탄산리조적불량사건발생솔분별위78%화69%.규류평재최대제량체800 mg/d적정황하내수성교호,기최상견적불량사건위편비(35%)、두훈(15%)화복사(10%);탄산리조최상견적불량사건위악심(17%)、편비(13%)화구토(13%).탄산리조중유3례환자인불량사건이중지연구,기중유1례위엄중불량사건;규류평조무인불량사건이중지적연구자.결론 규류평단약치료쌍상장애급성조광유효,차내수성교호.
Objective To evaluate the efficacy and safety of quetiapine fumarate as mono-therapy for acute mania in patients with bipolar disorder.Methods The study design was randomized,double blind,double dummy.lithium controlled.multicenter trial.Patients with bipolar disorder were hospitalized for the treatment of an acute manic episode according to the Chinese Classification of Mental Disorders 3rd edition criteria.and with the Young Mania Rating Scale(YMRS)total score≥20 were randomized to receive quetiapine(twice daily up to 800 mg/d)or lithium(twice daily up to 2000 mg/d).The primary endpoint was the change of YMRS total score from baseline to Day 28(last observation carried forward;LOCF).The safety was evaluated with the rate of adverse events(AEs),laboratory test and ECG.Results The ITTincluded 154 subjects.with 77 in each treatment group.Mean doses were 642.9 mg/d and 1377.7 mg/d for quetiapine and lithium respectively.Changes of YMRS total score from baseline to Day 28 in quetiapine and lithium group were-18.2 and-15.9,respectively.At Day 28,the response rate was significantly higher in quetiapine-treated patients(78%vs.60%;P=0.013).Quetiapine was well tolerated up to doses of 800 mg/d,and 78%of patients in quetiapine group and 69%in lithium group reported AEs.The most frequently reported AEs in quetiapine group were constipation(35%),dizziness(15%),and diarrhea (10%),and in lithium group were nausea(17%),constipation(13%),and vomiting(13%).Three subjects in lithium group but none in quetiapine group withdrew due to AEs.Conclusions The study resuhs support that quetiapine monotherapy is effective and well tolerated in the treatment of acute mania.
